Assessment of the Predictive Value of the Extreme Drug Resistance (EDR) Assay in Patients Receiving Paclitaxel for Metastatic Breast Cancer
OBJECTIVES: I. Evaluate the proportion of patients with extreme, intermediate, and low drug
resistance to paclitaxel using the Extreme Drug Resistance (EDR) Assay in patients with
previously treated metastatic breast cancer. II. Assess response to paclitaxel therapy in
patients who have undergone a pretreatment EDR assay. III. Assess time to tumor progression
during paclitaxel therapy in patients who have undergone a pretreatment EDR assay. IV.
Determine prospectively the predictive value of the EDR assay relative to clinical outcome
by correlating assay results with clinical tumor response and time to tumor progression
during paclitaxel therapy in these patients.
OUTLINE: This is an open label, single arm, blinded study. Patients' tumor tissue samples
are collected by excisional biopsy, core biopsy, or malignant fluid aspiration, then tested
by the Extreme Drug Resistance (EDR) Assay to determine probability of drug resistance to
paclitaxel. After successful completion of the EDR assay (approximately 7 days), patients
receive paclitaxel by intravenous infusion over 1-3 hours; treatment is repeated every 3
weeks. Treatment continues until there is documented evidence of tumor progression or
unacceptable toxicity. Patients' clinical response to paclitaxel therapy is compared with
the response predicted by the EDR assay.
PROJECTED ACCRUAL: 100 patients will be accrued to this study.
Primary Purpose: Diagnostic
Rita S. Mehta, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Chao Family Comprehensive Cancer Center||Orange, California 92868|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Louisiana State University Health Sciences Center - Shreveport||Shreveport, Louisiana 71130-3932|
|Pacific Coast Hematology/Oncology Medical Group||Fountain Valley, California 92708|
|Long Beach Memorial Breast Center||Long Beach, California 90806|
|Howard University||Washington, District of Columbia 20059|
|Palmetto Hematology/Oncology Associates||Spartanburg, South Carolina 29303|